Class II · Moderate risk
Enalapril Maleate Tablets
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Vasotec (enalapril maleate)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0141-30 5 mg 90 ct - NDC 0187-0141-90 10 mg 30 ct - NDC 0187-0142-30 10 mg 90 ct - NDC 0187-0142-90 10 mg 1000 ct - NDC 0187-0142-10 20 mg 30 ct - NDC 0187-0143-30 20 mg 90 ct - NDC 0187-0143-90 20 mg 1000 ct - NDC 0187-0143-10 NDC #'s 64455-140, 64455-141, 64455-142 and 64455-143, 30 ct. bottles, 90 ct. bottles and 1000 ct. bottles
Affected NDCs
0187-0140-90
0187-0141-30
0187-0141-90
0187-0142-10
0187-0142-30
0187-0142-90
0187-0143-10
0187-0143-30
0187-0143-90
64455-0140
64455-0141
64455-0142
Compare with the code on your package — it is the most precise check available.
Drug: Enalapril Category: Blood Pressure Medication
Product details
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Vasotec Enalapril Maleate NDC 00187-0140 |
2.5 mg/1 | Tablet Oral |
Bausch Health US LLC | Rx |
| Vasotec Enalapril Maleate NDC 00187-0141 |
5 mg/1 | Tablet Oral |
Bausch Health US LLC | Rx |
| Vasotec Enalapril Maleate NDC 00187-0142 |
10 mg/1 | Tablet Oral |
Bausch Health US LLC | Rx |
| Vasotec Enalapril Maleate NDC 00187-0143 |
20 mg/1 | Tablet Oral |
Bausch Health US LLC | Rx |
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- NDC code
- 0187-0140-90
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0019-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Enalapril recalls
See all
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Other recalls by Valeant Pharmaceuticals North America LLC
All 2014 recalls
Class III · Low risk
Diltiazem HCl CD capsules
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
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